Recruiting
Phase 3

I-125 vs. Pd-103

Sponsor:

VA Puget Sound Health Care System

Code:

NCT00486499

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

I-125 versus Pd-103 radioactive seed insertion

Study Details

Brief summary:

hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Conditions

Prostate Cancer

Study ID

NCT00486499

Start date

Mar, 2003

Status verified date

Jun, 2007

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PSA 4-10 ng/ml
  • Gleason score 5 or 6

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

I-125 versus Pd-103 radioactive seed insertion

Primary outcome measure

  • PSA-based cancer eradication [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

kent E Wallner, md

206-768-5356kent.wallner@med.va.gov

Locations

Group Health Cooperative

Recruiting

Seattle, Washington, United States, 98104

Contacts

Kent E Wallner, MD

206-326-3490kent.wallner@med.va.gov

Principal Investigator:

Kent E Wallner, MD

VA Puget Sound

Recruiting

Seattle, Washington, United States, 98108

Contacts

Kent E Wallner, MD

206-768-5356kent.wallner@med.va.gov

Principal Investigator:

Kent E Wallner, MD

More Information

Sponsor

VA Puget Sound Health Care System

Last update posted

Jun 14, 2007

Last verified

Jun, 2007

Keywords

  • radiation
  • brachytherapy
  • prostate
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Puget Sound Health Care System on 2007-06-14.